FDA 510(k) clearances — page 615
clearances on record, most recent first.
Clearances — page 615
61,401–61,500 of 175,825- K052206 — ZEUS MALE CONDOM APPLICATOR
- K061668 — OPTECURE +CCC
- K062160 — GO GO MINI, MODEL SC30
- K062408 — SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
- K062427 — VERTE-STACK SPINAL SYSTEM
- K062509 — INCORIS ZI
- K060329 — ENDOFAST RELIANT SYSTEM
- K061432 — HOSPIRA ENTERAL FEEDING SET, MODEL 20640
- K061471 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
- K061515 — RENALSOFT
- K061611 — BOSWORTH DENTIN RESIN
- K061648 — DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
- K061795 — DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
- K061802 — DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
- K061973 — SYNTHES 3.5MM SPRING PLATE
- K062022 — HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K062039 — BIOPSY DIGIT-AM
- K062058 — ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
- K062062 — VOYAGER PACS SYSTEM
- K062196 — SFX SNAP-FIT CROSS CONNECTOR
- K062229 — CTC WORKSTATION, MODEL 2200
- K062234 — MODIFICATION TO DIADEXUS PLAC TEST
- K062239 — GLUCOSE HK NEW FORMULATION TEST SYSTEM
- K052968 — MODIFICATION TO: ORLUS MINI SCREW
- K060333 — DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
- K060700 — EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
- K061008 — QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
- K061410 — SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT
- K061591 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K061664 — FORMCORE DC, MODEL 28-700100
- K061688 — ANTI-SNORING / SLEEP APNEA DEVICE
- K061717 — ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
- K061735 — INFIBRA, MODEL 1200
- K061835 — STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE
- K061940 — SYNTHES LCP ANKLE ARTHRODESIS PLATES
- K062206 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML
- K062291 — VPAP MALIBU WITH H2I
- K062315 — SUPERDIMENSION/BRONCHUS PREMIUM 2
- K062348 — TIMESH SELF DRILLING SCREW
- K062404 — TRANSEAR BONE CONDUCTION HEARING AID
- K062420 — 5F SHERPA ACTIVE NX GUIDE CATHETER
- K062483 — MINI POWER CHAIR, MODEL MN 5000
- K062506 — INCORIS AL
- K062522 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K051165 — KLS MARTIN STERNAL TALON
- K052523 — PROXIS SYSTEM
- K060182 — TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE
- K061785 — CYL-FIL OXYGEN SYSTEM
- K062048 — AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM
- K053418 — SYNTHES OC FUSION SYSTEM
- K053540 — INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE
- K060180 — BIOSET XC
- K060623 — SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
- K060765 — HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
- K061394 — SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
- K061663 — ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
- K061731 — MEDGRAPHICS ULTIMA SYSTEM
- K061742 — URYXXON RELAX URINE ANALYZER
- K061764 — MEDIBYTE, MODEL MP8
- K061825 — DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
- K061884 — BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120
- K061961 — ART LAB SOFTWARE
- K061995 — XCELERA
- K062034 — DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
- K062042 — PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
- K062059 — AIE REGION OF INTEREST IMAGE ENHANCEMENT
- K062067 — TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
- K062199 — DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
- K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
- K062392 — PHILIPS MP5 INTELLIVUE PATIENT MONITOR
- K062407 — GATEWAY THORACOLUMBAR PLATE SYSTEM
- K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM
- K052492 — AIRNERGY+STREAM
- K052532 — IMAX 9.5 STERILIZERS
- K060734 — FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
- K060948 — PORTRAIT PSR3
- K061224 — LAPDOC I
- K061364 — PILOT POSTERIOR LUMBAR PLATING SYSTEM
- K061442 — PULSE OXIMETER, MODEL PM-50
- K061635 — MSD BIPOLAR FORCEPS
- K061759 — REPROCESSED EXTERNAL FIXATION DEVICE
- K061781 — MULTILINK SPRINT
- K061874 — INVACARE'S TWILIGHT II NASAL MASKS
- K061924 — CORONIS 3MP AND MDCG 3120-CB
- K061927 — CORONIS COLOR 3MP AND MDCC 3120-DL
- K061928 — CORONIS COLOR 2MP AND MDCC 2121
- K061958 — MEDTRONIC EXPORT XT CATHETER
- K061960 — FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
- K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE
- K062159 — RB12 SUCTION RECTAL BIOPSY SYSTEM
- K062281 — ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
- K062504 — CERAMAX
- K060165 — AXYAFLEX POLYESTER SUTURE
- K060288 — RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
- K060882 — EXCEL BOND DC, MODEL 28-200100
- K061075 — BOOMERANG WIRE
- K061134 — EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
- K061231 — WELLFLEX BILIARY RX STENT SYSTEM
- K061564 — PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
- K061649 — POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH
Data sourced from openFDA. This site is unofficial and independent of the FDA.